Cancer Policy Monitor: July 10, 2018      

NIH Appropriations Update from Capitol Hill       

On June 28, the Senate Appropriations Committee advanced the Senate Appropriations Labor, Health and Human Services, and Education's (Labor-HHS-Ed) fiscal year (FY) 2019 spending bill. The bill includes $39.1 billion for the National Institutes of Health (NIH), a $2 billion proposed increase over FY 2018. The full Senate has yet to vote on the bill, but Senate Majority Leader Mitch McConnell (R-Kentucky) had indicated that he would like to have all appropriations bills completed and voted on before the end of the 2018 fiscal year on September 30.

In a statement released after the bill advanced to the full Senate, the AACR commended Chairman Roy Blunt (R-Missouri) and Ranking Member Patty Murray (D-Washington) for proposing this $2 billion increase for NIH and applauded their continued, bipartisan efforts to provide robust, sustained, and predictable funding increases for NIH. 

“Chairman Blunt and Senator Murray are two of our staunchest champions on Capitol Hill for the lifesaving scientific discoveries that are supported by the NIH, and we are deeply grateful for their continued efforts to make medical research a national priority,” said AACR Chief Executive Officer Margaret Foti, PhD, MD (hc) in a statement. “The proposal that these two visionary leaders have put forward would continue a trend that they began in 2015 to provide significant annual budget increases to NIH. We look forward to working with Chairman Blunt, Senator Murray, their staff, and their Senate colleagues in the coming months to build upon the considerable support for the NIH we have seen over the past few years.”

The action on the Senate Labor-HHS-Ed spending bill follows work in the equivalent House Subcommittee, which had proposed a $1.25 billion funding increase for NIH in FY 2019.  House Subcommittee Chairman Tom Cole (R-Oklahoma) was provided with a smaller overall budget allocation than what his Senate colleagues were given to disseminate across the many important programs they oversee, which accounts for the lower proposed increase for NIH in the House bill. Chairman Cole has indicated that as in recent years, Congress would likely agree on an NIH funding level closer to the Senate proposal. The AACR also applauded Chairman Cole for his strong leadership and enduring commitment to NIH. The full House Appropriations Committee is scheduled to vote on the House Labor-HHS-Ed spending bill on Wednesday, July 11.

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AACR to Host Congressional Briefing on E-Cigarettes     

E-cigarettes were the most commonly used tobacco product among U.S. middle school and high school students for the fourth year in a row according to a 2018 CDC Report. Among youth who had used an e-cigarette, 17 percent indicated their reason for use was that they believe they are less harmful than other forms of tobacco such as cigarettes. While e-cigarettes are likely less harmful to health than combustible cigarettes, there is also clear evidence that vaping can cause harm, especially when initiated at a young age. Because these products are new, many of the potential long-term harms are still unknown. As such, the U.S. Surgeon General recently declared e-cigarette use in young Americans a major public health concern.  

The quickly rising rates of e-cigarette use in this population and high nicotine content of popular products like Juul have raised questions of whether we are now at high risk for addicting another generation to the harmful effects associated with nicotine.

This briefing will update the audience on the latest science pertaining to the effects and content of e-cigarettes and will discuss the growing problem of youth use of e-cigarettes including a first-hand perspective of their impact from a reporter with The New Yorker. In addition, expert speakers will offer potential solutions for halting the alarming rise in youth e-cigarette use, balanced with a need for research into whether these products could be effectively used for supporting smoking cessation in current adult nicotine users.

Learn more and to RSVP.

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Apply Today: Scientist↔Survivor Program at the Science of Cancer Health Disparities Conference      

The 11th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, to be held Nov. 2-5, 2018, will address all levels of basic, population, clinical, and transdisciplinary research related to cancer.

The goals of this conference are to bring together physicians, scientists, health professionals, and health care leaders working in a variety of disciplines to discuss the latest findings in their fields; foster collaborative interdisciplinary interactions and partnerships; and stimulate the development of new research in cancer health disparities.

Patient advocates who participate in the Scientist↔Survivor Program at the Science of Cancer Health Disparities Conference will:

  • Discuss relevant and timely cancer topics with scientific mentors during small group meetings and roundtable discussions;
  • Attend scientific talks at the Cancer Health Disparities Conference on their own or with their scientific mentors and other advocates;
  • Create and present at the poster session;
  • Communicate to scientists the key issues, questions, and concerns of the survivor and patient advocacy communities; and
  • Network with scientists and fellow advocates from local, national, and international cancer organizations.

Scientist↔Survivor Program participants are accepted by competitive application. Patient advocates are encouraged to apply to the Scientist↔Survivor Program in conjunction with the Science of Cancer Health Disparities Conference by July 23, 2018 if they:

  • Actively support cancer research through policy advocacy, research advocacy and/or community outreach;
  • Have a constituency with which to share the knowledge they gain through the program;
  • Are in a position to communicate the knowledge gained from the program to colleagues and/or constituents and have access to avenues for disseminating this information;
  • Are able to participate in all components of the four-day program in New Orleans.

Learn more and apply here.

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Capitol Corner: AACR Interviews Members of Congress      

Every month, the AACR will be interviewing several members of Congress from both sides of the aisle to get their personal story and views on cancer research. This month, we interviewed Senator Maggie Hassan (D-New Hampshire) and Congresswoman Kristi Noem (R-South Dakota).

Read our previous interviews with Senator Johnny Isakson (R-Georgia), Congressman Joseph Crowley (D-New York), Senator Jon Tester (D-Montana), Congressman Dave Reichert (R-Washington), Senator Gary Peters (D-Michigan), Congressman Charlie Crist (D-Florida), Senator Susan Collins (R-Maine), Congressman Dwight Evans (D-Pennsylvania), Senator Chuck Grassley (R-Iowa), Senator Tammy Baldwin (D-Wisconsin), Congressman Brett Guthrie (R-Kentucky) and Congresswoman Suzan DelBene (D-Washington).

Senator Maggie Hassan (D-New Hampshire) 

Can you share with our readers, many of whom are cancer survivors, advocates, and researchers, your personal connection to cancer?

Like far too many people, I have experienced the pain of losing a loved one, my father, to cancer, and have close family members who are breast cancer survivors. As a senator and a member of the Health, Education, Labor, and Pensions Committee, these experiences – along with the experience of having a son who experiences severe disabilities – help inform my approach to health care issues. 

How has the experience of dealing with cancer in your community, both personally and from stories you’ve heard from your constituents, shape your views as a policymaker and a public official?

Over the course of policy debates, including recent partisan efforts to repeal the Affordable Care Act, my constituents share with me some of their most personal health stories. These stories are critical to being able to put a face on the implications that decisions in Washington can have, and in fighting for essential health care priorities. We need to ensure that people have quality, affordable health insurance, and increase support for medical research to find a cure for this disease that has taken far too many of our friends, family, and fellow Americans.

In your first year as a senator, you’ve expressed great support for medical research and the National Institutes of Health (NIH), as well as for early-career research, and you opposed proposed cuts to the NIH budget last year. Why do you believe that NIH funding is so important? What would you say to your colleagues in the legislative branch who may not understand as you do how important federal investment in medical research is to our nation?

The National Institutes of Health is the largest biomedical research agency in the world, providing medical researchers across the country with grant funding to support the treatment, reduction, and eradication in illnesses. The NIH is not only critical to the health and well-being of our people, but also to New Hampshire’s economy – supporting more than 1,500 jobs in the Granite State in 2016 and helping our country stay competitive globally.

President Trump’s proposal to slash NIH funding would obviously undermine the capacity of the NIH to provide this value and I think advocates would do well to remind lawmakers that the NIH is unique in its capacity to provide quality oversight of and leverage, new scientific developments. We must continue working to make a robust federal investment in medical research in order to strengthen the health and well-being of our people, our communities, and our country. That is why I joined in calling on the Senate Appropriations Committee to maintain a strong commitment to funding for the NIH in the appropriations process. 

How can groups like the AACR and patient advocates best communicate the importance of medical research to the members of Congress?  Do you think we have made progress in terms of raising awareness of the importance of National Institutes of Health (NIH) funding to saving lives and helping the American economy? 

Hearing the voices and priorities of AACR and patient advocates is critical to our work at the federal level to support medical research, providing us with important context as we make decisions pertaining to the NIH. AACR members should continue to speak up – not only to your elected officials, but also in your communities – to your friends, neighbors, and coworkers. This helps build grassroots support for the NIH, which is critical. I look forward to continuing to work together to build a stronger, healthier United States of America, and I encourage AACR and patient advocates to keep speaking out about the importance of the NIH to helping save lives and supporting our economy.

Can you tell us more about other efforts—legislation and otherwise—that you have worked on or are currently working on in support of better prevention, detection and treatment of cancer? 

As Governor of New Hampshire, I worked to address the health and environmental concerns raised by a pediatric cancer cluster on the seacoast in New Hampshire. We formed the Governor’s Task Force on the Seacoast Cancer Cluster to help create an organized response to those concerns, and urged the EPA to set a lifetime health advisory for certain perfluorinated chemicals (PFCs) to help states assess the safety of drinking water. 

In the Senate, I have continued efforts to protect Granite Staters from emerging contaminants in drinking water, including cosponsoring legislation to require the EPA to develop a maximum contaminant level for PFCs and to identify a threshold of expected risk to health for PFCs within two years of the bill’s enactment. I also supported a provision authored by Senator Shaheen in the FY 2018 National Defense Authorization Act to create the first-ever nationwide health study on the effects of PFCs in drinking water. I will continue working to ensure that communities throughout New Hampshire and across the country have the information they need to keep families safe and to protect public health.  

To support medical research that is critical to finding a cure to cancer, I am cosponsoring legislation to increase funding for targeted biomedical research initiatives through a new funding stream that would support the NIH and Food and Drug Administration. I have also called on the Senate Appropriations Committee to continue supporting valuable medical research conducted by the Department of Defense through the Congressionally Directed Medical Research Program, which is critical to advancing our understanding of a variety of health issues and has contributed to important medical breakthroughs. 

The AACR is the world’s first and largest organization dedicated to every aspect of high quality cancer research. The AACR has 40,000 members across all states, as well as members in over 119 other countries. Do you have anything you would like to say to the AACR and our scientists and physicians who have dedicated their careers to making progress against cancer?

Thank you to all of the scientists, physicians, medical professionals, patient advocates, and AACR members for dedicating your lives to the fight against cancer. Your work is inspiring and I am encouraged by the breakthroughs we are seeing in medical research, including in the immunotherapy realm with CAR-T cell therapy as well as CRISPR and other gene editing technologies.

Your efforts are critical to strengthening the health and well-being of our people, communities, and entire country, and I will continue working every day to ensure that you have the support and resources you need to continue your important work to ultimately find an end to this devastating disease.

Is there anything we didn’t discuss that you would like to add?

In a democracy based on the principle that everyone counts, it is essential that we have a strong, federally funded medical research agency and extended scientific community that can work to better the lives of all Americans by ensuring that they have access to cutting edge medical treatments and research. There is no substitute for good health, and the strength of our democracy can be measured by how well we do in developing – and making available to all – the science and technology that will allow all of our  people the freedom that comes with having good health.

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Congresswoman Kristi Noem (R-South Dakota)  

Can you share with our readers, many of whom are cancer survivors, advocates, and researchers, your personal connection to cancer?

Both my grandma and grandpa passed away from cancer, but just before Christmas, I was hit hard with news from a dear family friend. A mother of four (all age 5 and under!), Danielle is now facing stage 4 breast cancer. She’s a fighter – always has been – but I recognize she has a big battle ahead. You don’t always know what to say in moments like this – particularly because I’ve never faced it myself. But I’m a woman of faith, as is Danielle, so I pray daily that she takes heart in this Bible verse: “Be strong and courageous. Do not be afraid or terrified… for the LORD your God goes with you; he will never forsake you.”

How has the experience of dealing with cancer in your community, both personally and from stories you’ve heard from your constituents, shape your views as a policymaker and a public official?

The impact of a cancer diagnosis isn’t only felt by the one who receives it. It’s felt by their spouse, their friends, their coworkers, their children. It forces you to shift your perspective, thinking beyond the clinical diagnosis and considering the impacts on a family’s finances, emotional wellbeing, and home life. As a policymaker, that wholistic understanding can shift your perspective. Yes, the patient’s medical needs are front and center, but one must also consider the impact of getting treatments to market that offer patients more good days, for instance, and thus give a parent more time to help with their kids’ homework. Those considerations might be just as important as the cure itself.

What would you say to your colleagues in the legislative branch about the role of federal investment in medical research and cancer research in our nation?

I am very concerned about the way federal regulations can stand in the way of research. Simply put, uprooting one’s life and temporarily moving to another country should not be the only way some families can gain access to the latest medical innovations. We must cut through the red tape and give individuals greater access to new research, particularly when all other options have failed. 

How can groups like the AACR and patient advocates best communicate the importance of medical research to the members of Congress? Do you think we have made progress in terms of raising awareness of the importance of NIH funding to saving lives and helping the American economy?

Never doubt the impact that telling your story can have. I remember one meeting I had with a girl in her early teens. She was in Washington, D.C., advocating on behalf of her younger sister who wasn’t able to make the trip herself. She sat across the table from me with three Zip-lock bags of Skittles – one marked daily, another weekly, and the other monthly. Each little Skittle represented a pill her sister took. Those three bags of Skittles represented what kept her sister alive. It was a powerful statement; one you won’t forget.

Can you tell us more about other efforts—legislation and otherwise—that you have worked on in support of better prevention, detection and treatment of cancer?

The 21st Century Cures Act, which was signed into law in 2016, was a huge step forward. In addition to lifting some of the regulatory burdens that have historically held back American innovation, the legislation took important steps in modernizing clinical trials and streamlining processes that make it difficult to translate discoveries into treatments for those who need them. Most importantly, 21st Century Cures puts patients at the forefront of research.

Do you have anything you would like to say to the AACR and our scientists and physicians who have dedicated their careers to making progress against cancer

Thank you! Because of your work, Danielle and her family have options they wouldn’t have had ten years ago. Whether you’re an advocate, a researcher or a physician, the time and effort you dedicate to this mission is changing people’s lives each and every day. Together, progress is being made.

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San Francisco Approves Ban on Flavored Cigarettes and E-cigarette Liquids      

San Francisco residents overwhelmingly voted last month to uphold a ban on all flavored tobacco products, to include menthol cigarettes and flavored e-cigarette liquids. The city's supervisors had approved the ban last summer, which was challenged by tobacco company R.J. Reynolds along with a coalition of businesses and industry associations.

R.J. Reynolds had spent more than $11.6 million on a campaign to persuade San Francisco residents to vote against the ban, but ultimately, nearly 70 percent of voters cast their ballots in favor of banning menthol cigarettes and flavored e-cigarette liquids. 

Menthol cigarettes make up about 35 percent of the tobacco industry’s total cigarette sales, according to Wells Fargo, and e-cigarettes are rising in popularity, particularly among youth. A 2018 CDC report showed that e-cigarettes are the most commonly used tobacco product among U.S. middle school and high school students for the fourth year in a row. 

Opponents of the ban had argued that e-cigarette flavors make them more appealing for smoking adults to use as smoking cessation devices, but proponents of the ban have countered that flavors such as “fruit medley” or “crème brûlée” make e-cigarettes more appealing to youth. 

Aside from San Francisco, Oakland, California, also has a similar flavor ban that was approved last year and will take affect later this year.

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TAILORx Trial Finds Most Women with Early Breast Cancer Don’t Benefit from Chemotherapy    

Recently-released results from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx trial, found that for 70 percent of women with the most common type of breast cancer (HR-positive, HER2-negative, node-negative breast cancer), did not benefit from chemotherapy. The findings suggest that chemotherapy may still be considered for the remaining 30 percent of women with HR-positive, HER2-negative, node-negative breast cancer. 

The goal of the TAILORx trial is to examine genes that are frequently associated with risk of recurrence for women with early-stage breast cancer and using these genes to recommend the most appropriate and effective treatments for these patients, potentially saving women from having to undergo unnecessary treatments that lack substantial benefit.

Participants in the study included more than 10,200 women who had been recently diagnosed with estrogen-receptor and/or progesterone-receptor positive, HER2/neu-negative breast cancer that had not yet spread to the lymph nodes. The study included participants in the U.S., Australia, Canada, Ireland, New Zealand, and Peru. The women were categorized into three recurrence risk groups depending on their score on the gene expression test and then provided with different treatment protocols depending on risk group.

The first set of results from the study were released in September 2015. The findings suggested that women who fall under the lowest risk group based on a gene expression test do not have to undergo chemotherapy. The latest results, released in June 2018, showed that for women in the intermediate risk group based on a gene testing, adjuvant hormone therapy alone worked as well as hormone therapy and chemotherapy combination, indicating that these women also do not have to undergo chemotherapy. For women in the highest risk group, chemotherapy may still be considered.

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NCI-MATCH Precision Medicine Clinical Trial Releases New Findings    

The National Cancer Institute's Molecular Analysis for Therapy Choice (NCI-MATCH) trial, the largest precision medicine trial of its kind, released results in June 2018 that could ultimately play a role in bringing targeted treatments to patients with certain gene abnormalities, regardless of cancer type. 

“These findings represent a large collection of data in populations of patients who may not have been studied in conventional clinical trials, and they will have important implications for future precision medicine trials,” said Lyndsay Harris, MD, acting associate director of NCI's Cancer Diagnosis Program and NCI study chair.

NCI-MATCH is a phase 2 clinical trial launched in August 2015 that includes adults who have solid tumors, lymphoma, or myeloma that failed standard treatment or rare cancers that have no standard treatment. The trial looks into whether therapies targeted against tumors with certain gene mutations identified with a DNA sequencing test would work regardless of cancer type. 

The first results from the trial, released in November 2017, showed that the drug nivolumab may have benefits in treatment of mismatch repair–deficient non-colorectal cancers. The latest set of results involve three different drugs: taselisib, ado-trastuzumab emtansine (T-DM1) and AZD4547. 

For patients with mutations in the PIK3CA gene treated with taselisib, results showed that 24 percent of the patients had progression-free survival of greater than six months, including patients who had aggressive cancer types, suggesting that the taselisib warrants further research.
Three of the 37 patients with HER2-overexpressing tumors treated with T-DM1, each of whom had a rare tumor type, had at least 30 percent shrinkage of the tumor. Additionally, 46 percent of the patients had stable disease, including patients with ovarian, uterine, and colorectal cancers, indicating that T-DM1 warrants further study, particularly in rare cancers.

For patients with mutations in the FGFR pathway treated with AZD4547, 10 percent had a partial response to the drug, including two patients with point mutations in the FGFR2/3 gene and two patients with FGFR3 gene fusions, suggesting that these mutations may be particularly sensitive to the drug.

The NCI-MATCH trial is still ongoing and currently enrolling patients at more than 1,100 cancer centers and community hospitals in all 50 states as well as Washington, D.C. and Puerto Rico.

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Materials Available: FDA-AACR-SGO Drug Development in Gynecologic Malignancies Workshop    

Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States, resulting in an unmet medical need. The ongoing revolution in oncology that has offered many new therapies to patients with a variety of cancer types has yet to reach these women. Last month, the AACR, FDA and Society of Gynecologic Oncology (SGO) held a workshop that provided a forum for open discussion between the FDA, clinicians, laboratory experts, and researchers on the way forward for treatment of gynecologic malignancies, including rare cancers.

The workshop included four sessions that focused on development of immunotherapy in gynecological malignancies, biomarker development and PARP inhibitors, and development of drugs for rare gynecological malignancies.

Learn more and access the workshop slides and videos.

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FDA-AACR Workshop: Non-clinical Models for Safety Assessment of Immuno-oncology Products    

On September 6, 2018, the AACR and FDA will host a workshop in Washington, D.C. to discuss current challenges and opportunities for non-clinical models to predict toxicities of immune checkpoint inhibitors and stimulators in patients. Registration is now open for participation in-person or via webcast. 

The development of non-clinical models that can predict toxicities of immune checkpoint inhibitors and stimulators in patients is an extremely important and timely issue for the cancer community. There are 50 agents targeting PD-1 or PD-L1 in clinical development, and more than 1100 trials combining anti-PD-1/L1 agents with other therapies, yet retrospective analyses indicate that animal toxicity for many of these agents is minimal and does not predict adverse effects in patients. 

In addition, the recent observation of worse overall survival in two randomized trials that evaluated anti-PD-1/L1 agents in combination with immunomodulatory drugs underscores the need for cross-sector collaboration in this area. With advances in nonclinical models to study the pharmacodynamics of immune checkpoint inhibitors and stimulators, the question remains whether any of these models could be adapted to assess the safety of immuno-oncology products.

Access the draft agenda, and register for in-person or webcast participation.

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Register Today: Rally for Medical Research 2018    

Registration is now available for the sixth annual Rally for Medical Research, which will be held Sept. 12-13, 2018, in Washington, D.C. For those who cannot participate in person, the online Rally National Day of Action will take place Sept. 13. Stay tuned to the Rally website for more info on the National Day of Action.

We have reserved a block of rooms at the Rally headquarters hotel at a negotiated rate. Contact to make a reservation at the lower rate.​​

Stay up-to-date on registration information by visiting the Rally website, Facebook, and Twitter pages. Learn more about 2018 Hill Day Sponsorship Opportunities​​.

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Join the AACR Cancer Action Alliance    

Millions of Americans are counting on us to continue the momentum and intensify our efforts to defeat the more than 200 diseases we know as cancer. There is no time to slow down.

By working together, we can make a difference and ensure that cancer research and biomedical science remain a strong national priority. Sign up and join the AACR Cancer Action Alliance to receive breaking news alerts an​d learn about opportunities to join other scientists, patients, survivors and concerned citizens in calling on Congress to provide critical funding increases for the lifesaving cancer and biomedical research supported by NIH and NCI.

Learn more and sign up.

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